Kaletra is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Hhs/program Support Center/supply Service Center. The primary component is Lopinavir; Ritonavir.
Product ID | 11819-342_ac8d96ed-3661-4b62-b4e2-c42c93042cf3 |
NDC | 11819-342 |
Product Type | Human Prescription Drug |
Proprietary Name | Kaletra |
Generic Name | Lopinavir And Ritonavir |
Dosage Form | Tablet, Film Coated |
Route of Administration | ORAL |
Marketing Start Date | 2010-06-18 |
Marketing Category | NDA / NDA |
Application Number | NDA021906 |
Labeler Name | HHS/Program Support Center/Supply Service Center |
Substance Name | LOPINAVIR; RITONAVIR |
Active Ingredient Strength | 200 mg/1; mg/1 |
Pharm Classes | HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA] |
NDC Exclude Flag | E |
Listing Certified Through | 2017-12-31 |
Marketing Start Date | 2010-06-18 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA021906 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2010-06-18 |
Inactivation Date | 2019-11-13 |
Ingredient | Strength |
---|---|
LOPINAVIR | 200 mg/1 |
SPL SET ID: | 0b126fcd-2385-409f-9269-5bf886649c1a |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
0074-0522 | Kaletra | Lopinavir and Ritonavir |
0074-1575 | Kaletra | Lopinavir and Ritonavir |
0074-2605 | Kaletra | Lopinavir and Ritonavir |
0074-3956 | Kaletra | Lopinavir and Ritonavir |
0074-6799 | Kaletra | Lopinavir and Ritonavir |
11819-342 | Kaletra | Lopinavir and Ritonavir |
21695-362 | Kaletra | lopinavir and ritonavir |
53808-0276 | Kaletra | lopinavir and ritonavir |
55289-947 | Kaletra | Lopinavir and Ritonavir |
68258-1972 | Kaletra | Kaletra |
70518-0091 | Kaletra | Kaletra |
66336-624 | Kaletra | Kaletra |
68071-2348 | Kaletra | Kaletra |
31722-556 | Lopinavir and ritonavir | Lopinavir and ritonavir |
31722-603 | Lopinavir and ritonavir | Lopinavir and ritonavir |
42385-933 | Lopinavir and Ritonavir | Lopinavir and Ritonavir |
42385-934 | Lopinavir and Ritonavir | Lopinavir and Ritonavir |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
KALETRA 75465750 2451327 Live/Registered |
ABBVIE INC. 1998-04-09 |